Traumatic Spinal cord injury
Conditions
Interventions
Product Name: Neuro-Cells
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: Nepla-tem-cel
Other descriptive name: AUTOLOGOUS BONE MARROW CONTAINING HEMATOPOIETIC
Sponsors
Neuroplast BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age range: 18 - 65 years 2. Complete (AIS grade A) or incomplete (AIS grade B or C) TSCI (ISNCSCI-assessed) at time of enrolment 3. Randomization can be done within 36-56 days (6-8 weeks) after the TSCI incident 4. Level of injury between C6 to T12 5. Voluntary signed informed consent by patients and Investigator before any trial-related procedures are performed Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. SCI AIS grade D or E at the start of enrolment 2. Allergic to mice antibodies and/or iron-dextran 3. Level of SCI above C6 or below T12 4. Positive HIV, hepatitis B or C serology 5. Positive Lues test 6. Total Nuclear Cell (TNC) count <1x109 TNC in bone marrow sample 7. Cancer, brain injury, disturbed consciousness, signs/symptoms of neurodegenerative disorder (e.g., stroke, amyotrophic lateral sclerosis, multiple sclerosis etc.), diabetes mellitus type 1, renal or cardiac insufficiency based on anamnesis history and at the investigator’s discretion 8. Any concomitant treatment or medication that interferes with the conduct of the trial, such as immune-suppressive medication or other medication (especially methotrexate, cyclosporine, and corticosteroids have to be avoided) known to interact with the anti- inflammatory and immune-modulative actions of stem cells (non-steroid anti-inflammatory drugs (NSAIDs) are allowed) 9. Abuse of alcohol (daily consumption of more than 2 units of alcohol containing drinks) or illicit drugs (e.g., heroin, cocaine, XTC) 10. Individuals that belong to vulnerable population groups 11. Females with childbearing potential without using adequate birth control methods (e.g., contraceptive pills, intrauterine devices (IUD), contraceptive injections (prolonged release), subdermal implantation, vaginal ring, or transdermal patches), and/or being pregnant or in the lactation period 12. Participation in any clinical trial (with exemption of descriptive studies with questionnaires and no active intervention) within the previous 30 days before enrolment, or simultaneous participation in such trial 13. Patients with extreme comorbidity before or after the TSCI are excluded at discretion of the PI 14. Patients who are unable to comply with the requirements of this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety: Characterize and confirm safety of intrathecal intervention of Neuro-Cells Efficacy: Investigate the effect of early administration of Neuro-Cells on the neurological (motor) condition at day 180 (visit 7);Secondary Objective: Secondary objectives: Investigate the effect of late administration of Neuro-Cells on the neurological (motor) condition Investigate the effect of Neuro-Cells on the autonomic and sensory neurological dysfunction, daily activity level, quality of life, pain perception, spasticity, use of pain-reducing and spasticity-reducing medication at day 180 (visit 7) for the early group and day 365 (visit 12) for both groups.;Primary end point(s): Primary Safety 90 days after treatment (visit 6 for early group, visit 11 for late group): - Physical examination status (checklist) - Biochemical changes in blood and urine Adverse events incidences and severity reported during the study (first to last visit) Primary efficacy: Increase in the American Spinal Injury Association motor scores (ASIAms) with additional 5 points. Baseline measurements (day 0, visit 2) are compared to day 180 (visit 7) for both early and late administration groups.;Timepoint(s) of evaluation of this end point: Day 0, 90 and 180 of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Day 0, 180 and 365 of study.;Secondary end point(s): Secondary efficacy: Increase in the American Spinal Injury Association motor scores (ASIAms) with additional 5 points. Baseline measurements (day 0, visit 2) are compared to day 180 (visit 7) for the early group and day 365 (visit 12) for the late administration group. In the early group the following secondary endpoints will be studied at baseline, day 180 and day 365 compared to the late administration group: - Increase in ASIA sensory scores ASIAss (pinprick and light touch), - Functional outcome using Spinal Cord Independence Measure (SCIM) III assessments - Pain perception and pain-reducing medication, - Spasticity measurements of the knee and hip flexor and extensor muscles using the Modified Ashworth Scale (MAS) and actual spasticity- reducing medication, General wellbeing: 3 question items QoL In the late group the following secondary endpoints will be studied at baseline and day 365 compared to the early administration group: - Increase in ASIA sensory scores ASIAss (pinprick and light touch), - Functional outcome using Spinal Cord Independence Measure (SCIM) III assessments - Pain perception and pain-reducing medication, - Spasticity measurements of the knee and hip flexor and extensor muscles using the Modified Ashworth Scale (MAS) and actual spasticity- reducing medication, General wellbeing: 3 question items QoL | — |
Countries
Spain
Contacts
Public ContactClinical Trial Information
Neuroplast BV
Outcome results
None listed